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510(k) K161455

Catalys Precision Laser System by Optimedica Corporation — Product Code OOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2016
Date Received
May 26, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmic Femtosecond Laser
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type

Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery.

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  • K100019 — PASCAL STREAMLINE PHOTOCOAGULATOR (May 4, 2010)
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  • K081744 — PASCAL SYNTHESIS DELIVERY SYSTEM (September 9, 2008)
  • K062336 — OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE (October 19, 2006)

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